Effect of Benralizumab on Airway Remodeling in Severe Asthma
BenRalizumab Effect on Airway Remodeling in Severe Eosinophilic asTHmatics
This study tests if the medication benralizumab can improve breathing and reduce airway changes in people with severe eosinophilic asthma compared to those getting standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Drugs / interventions | Benralizumab |
| Locations | 1 site (Thessaloniki) |
| Trial ID | NCT06288516 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of benralizumab, a monoclonal antibody targeting interleukin-5, in patients with severe eosinophilic asthma. The study aims to assess airway remodeling and identify biomarkers that may predict patient response to treatment. Participants will undergo bronchoscopy and other assessments to measure inflammatory cells and biomarkers before and after treatment. The trial includes a control group of severe asthmatics receiving standard care for comparison.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of severe eosinophilic asthma who have experienced exacerbations despite high-dose inhaled corticosteroids.
Not a fit: Patients with non-eosinophilic asthma or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with severe eosinophilic asthma, enhancing their quality of life.
How similar studies have performed: Other studies targeting interleukin-5 in severe asthma have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent must be obtained at screening visit, before any assessment will be performed. Subjects should be able to provide informed written consent (study participation informed consent form): Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials. * Confirmed severe asthma diagnosis and treatment requirements according to American Thoracic Society(ATS)/European Respiratory Society (ERS) guidelines and Global Initiative for Asthma (GINA) 2023. * Blood eosinophils ≥150cells/ul at screening visit or ≥300cells/ul the last 12 months. * Patients with history ≥ 1 exacerbation the previous year under the treatment of high dose of inhaled corticosteroid(ICS)+LABA±LAMA or receiving oral/systemic corticosteroids at least 3 days. For subjects on maintenance oral corticosteroids, an exacerbation requiring oral corticosteroids was defined as the use of oral/systemic corticosteroids at least double the existing dose for at least 3 days. * Meet requirements for biologic therapy with Benralizumab. Exclusion Criteria: * Asthma exacerbation, within 6 weeks prior to screening that required hospitalization or emergency room visit. * Prior use of other biologics that has potential to interfere/ affect disease progression. * Pregnant or nursing women, or women of child-bearing potential. * History of malignancy of any organ system or any other serious co-morbidities defined by the treating physician. * Patients with a history of conditions other than asthma that could result in elevated eosinophils (e.g. hypereosinophilic syndromes, Churg-Strauss Syndrome, eosinophilic esophagitis).
Where this trial is running
Thessaloniki
- Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital — Thessaloniki, Greece (Recruiting)
Study contacts
- Principal investigator: Kalliopi Domvri, Dr — Aristotle University Of Thessaloniki
- Study coordinator: Kalliopi Domvri, Dr
- Email: kdomvrid@auth.gr
- Phone: 00306940904246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.